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IRCT20181111041611N8 IRCT 2023-08-07 Kermanshah University of Medical Sciences The effect of MIND diet in diabetic patients with insomnia The effect of MIND (Mediterranean-DASH Intervention for Neurodegenerative Delay) diet pattern on sleep status, anxiety, depression, and cardiometabolic indices in overweight or obese diabetic women with insomnia: A randomized controlled clinical trial 2023-08-19 anticipated 44 Complete https://irct.ir/trial/71772 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The random sequence is generated using the random block method. For random allocation of people, 11 blocks with 4 permutations will be created. The person collecting the information does not know anything about how the samples are assigned to the study groups. In performing the random assignment, the following points are considered: a) Each group is assigned an English letter: A to the low calorie MIND diet group, B to the normal low calorie diet group b) An order for sample size 44 is prepared. c) For the concealment procedure of random assignment, 44 opaque envelopes and 44 cards are prepared. In each envelope, 4 cards are placed in order in each block. The block numbers are written on each envelope. The name of the desired group is written on each card in turn. N/A Type 2 diabetes. Intervention 1: Intervention group: Receive a low-calorie MIND diet for 3 months. The required energy will be calculated based on the World Health Organization equations and 500 kcal will be deducted from the calculated energy amount. 50-55% of calories come from carbohydrates, 30% from fat and 15-20% from protein, which will be included in 3 meals and 3 snacks. In this dietary pattern, the consumption of green leafy vegetables, other vegetables, berries, nuts, whole grains, fish, beans, chicken and poultry, and olive oil is recommended, while the consumption of butter and stick margarine, cheese, red meat, fried and fast foods, and pastries and sweets is restricted. In this study, due to the ban on wine, it will be recommended to consume raisins and currants in calculated amounts. Intervention 2: Control group: Receive a low-calorie MIND diet for 3 months. The required energy will be calculated based on the World Health Organization equations and 500 kcal will be deducted from the calculated energy amount. 50-55% of calories come from carbohydrates, 30% from fat and 15-20% from protein, which will be included in 3 meals and 3 snacks. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information.
public Seyed Mostafa Nachvak
Isar St, Kermanshah
Kermanshah Iran (Islamic Republic of) 6719851552 +98 83 3710 2003 smnachvak@hotmail.com Kermanshah University of Medical Sciences scientific Seyed Mostafa Nachvak
Isar St, Kermanshah
Kermanshah Iran (Islamic Republic of) 6719851552 +98 83 3710 2003 smnachvak@hotmail.com Kermanshah University of Medical Sciences Iran (Islamic Republic of) Women with type 2 diabetes Desire to participate in the study Age range from 30 to 65 years old Body mass index between 25 and 35 kg/m2 Suffering from insomnia disorder, based on the Insomnia Severity Index (ISI) questionnaire, with scores above 7 30 years 65 years Female Insulin use Pregnancy and lactation Alcohol and smoking Sleep apnea Shift work Special diets and medications for weight loss in the last 3 months Suffering from other endocrine, metabolic, kidney and neurological diseases Taking medications (sedatives, painkillers, sleeping pills, etc.) other than blood sugar, lipid, and blood pressure lowering medications E11.6 Type 2 diabetes mellitus with other specified complications Other Placebo Intervention group: Receive a low-calorie MIND diet for 3 months. The required energy will be calculated based on the World Health Organization equations and 500 kcal will be deducted from the calculated energy amount. 50-55% of calories come from carbohydrates, 30% from fat and 15-20% from protein, which will be included in 3 meals and 3 snacks. In this dietary pattern, the consumption of green leafy vegetables, other vegetables, berries, nuts, whole grains, fish, beans, chicken and poultry, and olive oil is recommended, while the consumption of butter and stick margarine, cheese, red meat, fried and fast foods, and pastries and sweets is restricted. In this study, due to the ban on wine, it will be recommended to consume raisins and currants in calculated amounts. Control group: Receive a low-calorie MIND diet for 3 months. The required energy will be calculated based on the World Health Organization equations and 500 kcal will be deducted from the calculated energy amount. 50-55% of calories come from carbohydrates, 30% from fat and 15-20% from protein, which will be included in 3 meals and 3 snacks. Sleep quality. Timepoint: Baseline and End-of-trial. Method of measurement: The Pittsburgh Sleep Quality Index. Fasting blood sugar. Timepoint: Baseline and End-of-trial. Method of measurement: Enzymatic method. HbA1C. Timepoint: Baseline and End-of-trial. Method of measurement: Photometric method. Insulin. Timepoint: Baseline and End-of-trial. Method of measurement: Elisa. Triglyceride. Timepoint: Baseline and End-of-trial. Method of measurement: Enzymatic method. Total cholesterol. Timepoint: Baseline and End-of-trial. Method of measurement: Enzymatic method. HDL Cholesterol. Timepoint: Baseline and End-of-trial. Method of measurement: Enzymatic method. Brain-derived neurotrophic factor. Timepoint: Baseline and End-of-trial. Method of measurement: Elisa. Hs-CRP. Timepoint: Baseline and End-of-trial. Method of measurement: Elisa. Cortisol. Timepoint: Baseline and End-of-trial. Method of measurement: Elisa. Total Antioxidant Capacity. Timepoint: Baseline and End-of-trial. Method of measurement: Calorimetric method. Total oxidant capacity. Timepoint: Baseline and End-of-trial. Method of measurement: Calorimetric method. GSH-Px. Timepoint: Baseline and End-of-trial. Method of measurement: Calorimetric method. Catalase. Timepoint: Baseline and End-of-trial. Method of measurement: Calorimetric method. SOD. Timepoint: Baseline and End-of-trial. Method of measurement: Calorimetric method. MDA. Timepoint: Baseline and End-of-trial. Method of measurement: Calorimetric method. Quality of life. Timepoint: Baseline and End-of-trial. Method of measurement: 36-Item Short Form Survey. Depression-anxiety-stress. Timepoint: Baseline and End-of-trial. Method of measurement: Depression Anxiety and Stress Scale-21 questionnaire. LDL Cholesterol. Timepoint: Baseline and End-of-trial. Method of measurement: Friedewald. Blood pressure. Timepoint: Baseline and End-of-trial. Method of measurement: Sphygmomanometer. Weight. Timepoint: Baseline and End-of-trial. Method of measurement: Digital scale. Body mass index. Timepoint: Baseline and End-of-trial. Method of measurement: Dividing weight (in kilograms) by the square of height (in meters). Waist circumference. Timepoint: Baseline and End-of-trial. Method of measurement: Tape measure. Hip circumference. Timepoint: Baseline and End-of-trial. Method of measurement: Tape measure. Waist to hip ratio. Timepoint: Baseline and End-of-trial. Method of measurement: Dividing waist circumference (in centimeters) by the hip circumference (in centimeters). Height. Timepoint: Baseline and End-of-trial. Method of measurement: Stadiometer. Waist to height ratio. Timepoint: Baseline and End-of-trial. Method of measurement: Dividing waist circumference (in centimeters) by the height (in centimeters). Insomnia. Timepoint: Baseline and End-of-trial. Method of measurement: Insomnia Severity Index. Insulin sensitivity. Timepoint: Baseline and End-of-trial. Method of measurement: QUICKI formula. Insulin resistance. Timepoint: Baseline and End-of-trial. Method of measurement: HOMA-IR formula. Pancreatic beta cell function. Timepoint: Baseline and End-of-trial. Method of measurement: HOMA-IR formula. Kermanshah University of Medical Sciences Approved 2023-07-30 Ethics Committee of Kermanshah University of Medical Sciences Building No.2, Research Council of Kermanshah University of Medical Sciences, Shahid Beheshti Boulevard, Kermanshah, Iran Kermanshah Kermanshah Iran (Islamic Republic of)